MigrainePhase 2NCT00483717
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
A Phase 2 study testing Ketorolac tromethamine in people with Migraine, run by Egalet Ltd at 1 site in Germany.
Trial summary
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Ketorolac tromethamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
- Onset of migraine prior to age 50;
- 2-8 moderate to severe migraine headaches per month
Who cannot join
- Subjects receiving any investigational drug within 30 days before study entry;
- More than 15 headache days per month;
- Known allergy or hypersensitivity to ketorolac and/or excipients;
- Allergy to aspirin or other NSAIDs;
- Currently receiving other NSAIDs or aspirin;
- Medical history that would preclude NSAID use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Read the detailed description
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
- Conditions
- Migraine
- Being tested
- Ketorolac tromethamine, Placebo
- Keywords
- Migraine, Ketorolac
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac tromethamineDrug
31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
PlaceboDrug
Intranasal (IN) placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intranasal Placebo Receives: Drug: Placebo |
| Ketorolac tromethamine | Experimental | Intranasal ketorolac tromethamine Receives: Drug: Ketorolac tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 2 hours after dosing
Secondary outcomes (7)
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 0.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 1 hour post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 1.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 3 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 4 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 24 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Measured: 48 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Whiting, Ph D, Study chair, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483717
- Sponsor's protocol ID
- ROX-2007-01
- Status last verified
- Sep 2016
- First submitted
- 5 Jun 2007
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT00483717
- Acronym / sponsor ID
- ROX-2007-01
- Conditions
- Migraine
- Keywords
- Migraine, Ketorolac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Detailed description
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntranasal Placebo |
| Ketorolac tromethamine | Experimental | Drug: Ketorolac tromethamineIntranasal ketorolac tromethamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
- Onset of migraine prior to age 50;
- 2-8 moderate to severe migraine headaches per month
Key exclusion criteria (6 listed)
- Subjects receiving any investigational drug within 30 days before study entry;
- More than 15 headache days per month;
- Known allergy or hypersensitivity to ketorolac and/or excipients;
- Allergy to aspirin or other NSAIDs;
- Currently receiving other NSAIDs or aspirin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac tromethamine31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) | Drug | Ketorolac tromethamine |
| PlaceboIntranasal (IN) placebo | Drug | Placebo |
Primary outcome
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
Time frame: 2 hours after dosing
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
7 secondary outcomes
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 0.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 1 hour post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 1.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 3 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 4 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 24 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Time frame: 48 hours post-dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Whiting, Ph D study chair
American Regent, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac tromethamine in people with Migraine, run by Egalet Ltd at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. (time frame: 2 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.